BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 23065381 · Received September 16, 2025

    Report

    Report Number
    3030306055-2025-00281
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 16, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN CLOUDY PD EFFLUENT. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED TO BE "TUBE WAS ACCIDENTALLY CUT BY THE PATIENT". IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR A DAY. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT AND CAREGIVER WERE RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680024 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H EXTRANEAL| NUTRINEAL PD4 2.5| PHYSIONEAL 1.36%